Bright Flow is a light-cured flowable composite resin. It comprises two different types of flowability (Low Flow and High Flow) and 9 shades depending on the intended use, which enables aesthetic and durable outcomes for anterior and posterior composite restorations.

AI/ML Overview

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device Name: Bright High Flow
Manufacturer: GENOSS Co., Ltd.

The provided document describes the performance bench testing and biocompatibility testing conducted to demonstrate that the Bright High Flow device meets its acceptance criteria. No clinical study or MRMC effectiveness study is mentioned, as this device appears to be a dental material.

1. Table of Acceptance Criteria and Reported Device Performance

Biocompatibility Testing

No.	Test	Acceptance Criteria	Reported Performance
1	Cytotoxicity	None cytotoxicity	Pass
2	Irritation	None oral irritation	Pass
3	Sensitization	None sensitization	Pass
4	Acute systemic	None systemic toxicity	Pass
5	Genotoxicity	None genotoxicity	Pass
6	Implantation	Biocompatible	Pass
7	Chronic toxicity	No chronic toxicity	Pass

Performance Bench Testing

No.	Items	Acceptance Criteria	Reported Performance
1	Visual	No impurities and No specific changes	Pass
2	Capacity	Capacity error of; Standard Capacity < ± 5%	Pass
3	Package	No damage	Pass
4	Sensitivity to Ambient Light	Must be physically uniform	Pass
5	Depth of Cure	More than 1.5 mm	Pass
6	Shade	Must be shade uniform	Pass
7	Color Stability	Color should be stable	Pass
8	Flexural Strength	More than 80 MPa	Pass
9	Water Sorption	Less than 40 µg/mm³	Pass
10	Solubility	Less than 7.5 µg/mm³	Pass
11	Radio-opacity	More than the same thickness of aluminum (More than Al)	Pass

2. Sample size used for the test set and the data provenance

The document does not explicitly state the sample sizes used for each test. The tests are bench tests and biocompatibility tests, not studies involving human subjects or patient data. The provenance of the data (country of origin, retrospective/prospective) is not specified beyond the fact that the manufacturer is based in Korea and the testing was conducted according to international standards (ISO).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable. The evaluations are based on standardized laboratory tests (ISO standards) rather than expert interpretation of clinical data. There is no mention of experts establishing ground truth for a test set in the context of this device's evaluation.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for clinical studies involving human interpretation or subjective assessments, which are not detailed for this device. The evaluation relies on objective measurements against defined standards.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was done. This device is a dental material (flowable composite resin) and its evaluation is based on material properties and biocompatibility, not AI assistance for human readers.

6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done

This information is not applicable. The device is a dental material, not an algorithm, so "standalone performance" in the context of AI is irrelevant. Its performance is measured directly through physical and chemical property tests.

7. The type of ground truth used

The ground truth used for the performance evaluations are international consensus standards (ISO 10993 for biocompatibility and ISO 4049 for dental polymer-based restorative materials). These standards define the acceptable range or threshold for specific material properties.

8. The sample size for the training set

This information is not applicable. As the device is a material, there is no "training set" in the context of machine learning. The manufacturing process and material formulation are developed based on established dental material science principles.

9. How the ground truth for the training set was established

This information is not applicable, as there is no "training set" for this type of device. The "ground truth" for developing the material is derived from scientific knowledge, material engineering, and performance requirements for dental restorative materials, as codified in relevant ISO standards.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA acronym is in blue, and the full name of the agency, "U.S. Food & Drug Administration," is in a smaller font size below the acronym.

November 30, 2020

GENOSS Co., Ltd. Hong Jeon Manager 1F, Gyeonggi R&DB Center, 105 Gwanggyo-ro, Yeongtong-gu, Suwon-si Suwon-si, 16229 KOREA

Re: K200155

Trade/Device Name: Bright High Flow Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF, EBC Dated: October 22, 2020 Received: October 22, 2020

Dear Hong Jeon:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Image /page/2/Picture/0 description: The image shows the word "GENOSS" in a stylized font. The first three letters, "GEN", are in a dark green color. The last three letters, "OSS", are in a lighter green color.

Indication for use

510(k) Number: K200155

Device Name: Bright High Flow

Indication for use:

Base/liner
Pit & Fissure sealant

Prescription Use __ V__ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Indication for use

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Image /page/3/Picture/1 description: The image shows the word "GENOSS" in green font. The first three letters, "GEN", are in a darker green, while the last three letters, "OSS", are in a lighter green. The letters are all capitalized and have a bold appearance. The word appears to be a logo or brand name.

510(k) Summary

12/20/2019

1. Company

	Submitter
Name	GENOSS Co., Ltd.
Address	1F, Gyeonggi R&DB Center / 226, 2F, GSBC, 105Gwanggyo-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, Korea
Phone/Fax	+82-70-7098-7541/ +82-31-888-5105
Contact person	HongJun Jeon / RAhjjeon@genoss.com
Summary Date	12/20/2019

2. Device Name

Proprietary name: Bright High Flow Regulation description : Light-cured Flowable Composite Resin Classification name: Tooth shade resin material

3. Predicate Device

K091388 G-aenial Universal Flo

4. Description

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5. Indication for use

1. Base/liner
1. Pit & Fissure sealant

6. Technological Characteristics

Bright High Flow has the similar technological characteristics as the predicate device; main material, indication for use and design. Technological characteristics of Bright High Flow, Gaenial Universal Flo are as following.

Device name	Bright High Flow	G-aenial Universal Flo
Manufacturer	Genoss Co., Ltd.	GC America, Inc.
510(k) Number	New Device	K091388
Clinical	Target population	Human tooth	Human tooth
	Purpose	Direct restoration	Direct restoration
	Site of application	Dentin, Enamel	Dentin, Enamel
	Clinical Performance	High flexural strength and strong bonding	High flexural strength and strong bonding
Biological	Materials	Methacrylate resins, Fillers(Barium glass, Silica)	Methacrylate resins, Fillers(Barium glass, Silica)
	Chemical Safety	Biocompatible	Biocompatible
	Sterilization	Non-sterile	Non-sterile
	Shelf-Life	2 years	3 years
Technical	Form	Paste	Paste
	Indication for use	1) Base / liner2) Pit & Fissure sealant	1) Direct restorative for Class I, IV, III,II and V cavities.2) Fissure sealant3) Sealing hypersensitive areas4) Repair of (in) direct aestheticrestorations, temporary crown &bridge, defect margins when margins

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Image /page/5/Picture/0 description: The image shows the word "GENOSS" in a stylized font. The first three letters, "GEN", are in a dark green color, while the last three letters, "OSS", are in a lighter green color. The letters are connected and have a rounded, modern look.

		are in enamel5) Blocking out undercuts6) Liner or base
Use	Prescription	Prescription
Depth of cure	ISO 4049:2009 7.10 (More than 1.5 mm)
Water Sorption	ISO 4049:2009 7.12 (Less than 40 $\mu g/mm^3$ )
Solubility	ISO 4049:2009 7.12 (Less than 7.5 $\mu g/mm^3$ )
Flexural Strength	ISO 4049:2009 7.11 (More than 80 MPa)
Radio-opacity	ISO 4049:2009 7.14 (More than the same thickness of aluminum)

7. Performance Data

Biocompatibility testing on the proposed Bright High Flow has been completed. Requirements for biological evaluation of the proposed device were based on FDA recognized concensus standard of ISO10993, "Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing." The biocompatibility test results show that the materials used in the design and manufacture of the components of the proposed device are non-toxic and non-sensitizing to biological bone and tissues with its intended use. The following biocompatibility tests were completed:

(P: Pass, F: Fail)

No.	Test	Method	Acceptance criteria	P/F	Report No.
1	Cytotoxicity	ISO 10993-5	None cytotoxicity	P	CDM-18-0061-12
2	Irritation	ISO 10993-10	None oral irritation	P	MTK-2018-000707
3	Sensitization	ISO 10993-10	None sensitization	P	MTK-2018-000706
4	Acute systemictoxicity	ISO 10993-11	None systemictoxicity	P	MTK-2018-000706
5	Genotoxocity	ISO 10993-3	None genotoxicity	P	MTK-2018-000705

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Image /page/6/Picture/0 description: The image shows the logo for GENOSS. The word "GENOSS" is written in a sans-serif font. The letters "GEN" are in a dark green color, while the letters "OSS" are in a lighter green color. The logo has a modern and clean design.

6	Implantation	ISO 10993-6	Biocompatible	P	BER-18-028
7	Chronic toxicity	ISO 10993-11	No chronic toxicity	P	BER-18-028

The proposed Bright High Flow was evaluated using the following performance bench testing to confirm the performance characteristics:

No.	Items	Method	Acceptance Criteria	P/F	File No.
1	Visual	ISO 4049	No impurities and No specific changes	P	CDM-18-0061-01
2	Capacity	ISO 4049	Capacity error of; Standard Capacity $\lt \pm 5%$	P	CDM-18-0061-02
3	Package	ISO 4049	No damage	P	CDM-18-0061-03
4	Sensitivity to Ambient Light	ISO 4049	Must be physically uniform	P	CDM-18-0061-04
5	Depth of Cure	ISO 4049	More than 1.5 mm	P	CDM-18-0061-05
6	Shade	ISO 4049	Must be shade uniform	P	CDM-18-0061-06
7	Color Stability	ISO 4049	Color should be stable	P	CDM-18-0061-07
8	Flexural Strength	ISO 4049	More than 80 MPa	P	CDM-18-0061-08
9	Water Sorption	ISO 4049	Less than 40 $\mu g/mm^3$	P	CDM-18-0061-09
10	Solubility	ISO 4049	Less than 7.5 $\mu g/mm^3$	P	CDM-18-0061-10
11	Radio-opacity	ISO 4049	More than Al	P	CDM-18-0061-11

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Image /page/7/Picture/0 description: The image shows the word "GENOSS" in a stylized font. The first three letters, "GEN", are in a dark green color. The last three letters, "OSS", are in a lighter green color.

All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the Bright High Flow met the established specifications necessary for consistent performance according to its intended use.

8. Conclusion

Based on the information provided in this premarket notification of GENOSS Co., Ltd. Concludes that Bright High Flow is acceptable and safe, substantially equivalent to predicate devices.

Regulation Number and Section

§ 872.3690 Tooth shade resin material.

(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.